Validation Engineer

Duties:
• Lead Development and execution of CD and PQ requirements for new projects.
• Develop and execute Requal protocols for various Thermal Systems (Autoclave, SIP, CTUs)
• Lead investigations on validation deviations where required.
• Identify and Implement Continiuos improvents inititives.
• Adhere to site EHS standards and reporting requirements.

Requirements

Skills:

Thermal Systems Validation Engineer core competences and qualifications:

1. Direct Experience with hands on qualification of Steam Sterilization Autoclaves and porous loads

2. Understanding of the EN285 Requirements and testing

3. Understanding of the Saturated Steam requirements, heat transfer and Sterilization kill kinetics

4. Understanding of the Cycle Development and Performance requirements for the Porous Load sterilization

5. Understanding and handling of the Biological Indicators used for Steam Sterilization

6. Understanding of the SIP (Steaming/Sterilization in Place) system... design and SIP CQAs

7. Direct Experience with hands on for SIP qualification

8. Understanding of the Filter Integrity Testing requirements for SIP applications

9. Direct Experience with hands on qualification of Depyrigenation Tunnel

10. Understanding of the Endotoxins and thermal Requirements for Depyrogenation cycle (dry heat)

11. Direct Experience with execution of Control Temperature Units and qualification requirements

12. Direct Experience using thermal acquisition systems

13. Understanding of the Aseptic Manufacturing processes

14. Understanding of the Quality System Elements:

a. Deviation

b. CAPA

c. Calibration

d. Preventative maintenance

e. Change Control

Skills: Thermal Systems Validation Engineer core competences and qualifications: 1. Direct Experience with hands on qualification of Steam Sterilization Autoclaves and porous loads 2. Understanding of the EN285 Requirements and testing 3. Understanding of the Saturated Steam requirements, heat transfer and Sterilization kill kinetics 4. Understanding of the Cycle Development and Performance requirements for the Porous Load sterilization 5. Understanding and handling of the Biological Indicators used for Steam Sterilization 6. Understanding of the SIP (Steaming/Sterilization in Place) system design and SIP CQAs 7. Direct Experience with hands on for SIP qualification 8. Understanding of the Filter Integrity Testing requirements for SIP applications 9. Direct Experience with hands on qualification of Depyrigenation Tunnel 10. Understanding of the Endotoxins and thermal Requirements for Depyrogenation cycle (dry heat) 11. Direct Experience with execution of Control Temperature Units and qualification requirements 12. Direct Experience using thermal acquisition systems 13. Understanding of the Aseptic Manufacturing processes 14. Understanding of the Quality System Elements: a. Deviation b. CAPA c. Calibration d. Preventative maintenance e. Change Control
Athlone County Westmeath Ireland

Salary Criteria